General interest items edited by Janice Flahiff

he foundation of evidence-based research has eroded and the trend must be reversed so patients and clinicians can make wise shared decisions about their health, say Dartmouth researchers in the journal Circulation: Cardiovascular Quality and Outcomes.

Drs. Glyn Elwyn and Elliott Fisher of The Dartmouth Institute for Health Policy & Clinical Practice are authors of the report in which they highlight five major problems set against a backdrop of “obvious corruption.” There is a dearth of transparent research and a low quality of evidence synthesis. The difficulty of obtaining research funding for comparative effectiveness studies is directly related to the prominence of industry-supported trials: “finance dictates the activity.”

The pharmaceutical industry has influenced medical research in its favor by selective reporting, targeted educational efforts, and incentivizing prescriber behavior that influences how medicine is practiced, the researchers say. The pharmaceutical industry has also spent billions of dollars in direct-to-consumer advertising and has created new disease labels, so-called disease-mongering, and by promoting the use of drugs to address spurious predictions.

Another problem with such studies is publication bias, where results of trials that fail to demonstrate an effect remain unpublished, but trials where the results are demonstrated are quickly published and promoted.

Is advertising a psychotherapy as “evidence supported,” any less vacuous than “Pepsi’s the one”? A lot of us would hope so, having campaigned for rigorous scientific evaluation of psychotherapies in randomized controlled trials (RCTs), just as is routinely done with drugs and medical devices in Evidence-based Medicine (EBM). We have also insisted on valid procedures for generating, integrating, and evaluating evidence and have exposed efforts that fall short. We have been fully expecting that some therapies would emerge as strongly supported by evidence, while others would be found less so, and some even harmful.

Some of us now despair about the value of this labeling or worry that the process of identifying therapies as evidence supported has been subverted into something very different than we envisioned. Disappointments and embarrassments in the branding of psychotherapies as evidence supported are mounting. A pair of what could be construed as embarrassments will be discussed in this blog.

This website is for informational and educational purposes. It does not represent the official policy of Division 12 or the American Psychological Association, nor does it render individual professional advice or endorse any particular treatment.

Readers can be forgiven for thinking otherwise, particularly when such websites provide links to commercial sites that unabashedly promote the therapies with commercial products such as books, training videos, and workshops. There is lots of money to be made, and the appearance of an endorsement is coveted. Proponents of particular therapies are quick to send studies claiming positive findings to the committees deciding on listings with the intent of getting them acknowledged on these websites.

But now may be the time to begin some overdue reflection on how the label of evidence supported practice gets applied and whether there is something fundamentally wrong with the criteria.

Now you see it, now, you don’t: “Strong evidence” for the efficacy of acceptance and commitment therapy for psychosis

On September 3, 2012 the APA Division 12 website announced a rating of “strong evidence” for the efficacy of acceptance and commitment therapy for psychosis. I was quite skeptical. I posted links on Facebook and Twitter to a series of blog posts (1,2, 3) in which I had previously debunked the study claiming to demonstrate that a few sessions of ACT significantly reduced rehospitalization of psychotic patients.

The phrase evidence-based medicine (EBM) was coined by Gordon Guyatt1 and then appeared in an article in The Rational Clinical Examination series in JAMA in 1992,2 but the roots of EBM go much further back. The personal stories of the origins of EBM were recently explored in a filmed oral history of some of the individuals most strongly associated with the birth of the movement (see Video, Evidence-Based Medicine: An Oral History).

JAMA and the BMJ invited 6 individuals (including us, with one of us as host, R.S.) who have played a prominent part in the development of EBM to participate in an oral history event and filming. Videos of this event and of interviews with 3 other EBM leaders (Box) have been woven together and may be accessed athttp://ebm.jamanetwork.com. Just 20 years after the term EBM began to be used, an early and informal history has emerged.

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Evidence-based medicine grew out of critical appraisal. When Gordon Guyatt, currently a professor of epidemiology and biostatistics and medicine at McMaster University, took over as director of the internal medicine residency program at McMaster in 1990, he wanted to change the program so that physicians managed patients based not on what authorities told them to do but on what the evidence showed worked. He needed a name, and the first was “scientific medicine.” The faculty reacted against this name with rage, arguing that basic scientists did scientific medicine. The next name was “evidence-based medicine”(Evidence-Based Medicine: An Oral History Video).

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In the Oral History Video, Sackett distinguishes EBM from critical appraisal because it combines research evidence with clinical skills and patient values and preferences.

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Guyatt acknowledges that in the 1992 JAMA article there was little about patient values.2 It was over the next 5 years that patient values and preferences became much more central, and since then strongly emphasized (Evidence-Based Medicine: An Oral History Video).

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Evidence-based medicine quickly became popular, Sackett believes, for 2 main reasons: it was supported by senior clinicians who were secure in their practice and happy to be challenged and it empowered young physicians—and subsequently nurses and other clinicians. Evidence-based medicine did, however, produce a backlash, particularly, says Sackett, “among middle-level guys who were used to making pronouncements,”

Negative studies are just as important to consumers as positive studies. They are essential blocks in the evidence base. They help everyone—consumers and health care providers—avoid interventions that don’t help.

A recent study in the New England Journal of Medicine, authored by six researchers at the National Heart, Lung, and Blood Institute (NHLBI), prompts some thoughts about studies with negative outcomes—and their importance in the entire research process.

In this report Dr. David Gordon, Dr. Michael Lauer, and their colleagues analyzed the 244 extramural, randomized clinical trials supported by NHLBI and completed between the years 2000 and 2011. The primary outcome was the time between completion of trials and publication of the main results in a peer-reviewed journal; the secondary outcome was the annual citation rates for these articles—i.e., how many times each article was cited in a given time period. The team also examined a number of trial characteristics that related to these questions, such as budget, number of participants, and whether the result was positive or negative.

Among the many interesting findings are that more than half of the studies analyzed (58 percent) yielded negative results. And intriguingly, of the 31 trials having the highest citation rates, only 8 (26 percent) had positive results. Studies supported by NHLBI, and indeed, studies supported by NCCAM, generally start with enthusiasm of the investigators, peer reviewers, and NIH. They generally start with the expectation (and indeed preliminary data) that the intervention being studied has the potential to improve patient outcomes. By and large, when no benefit is demonstrated, research teams are understandably disappointed. And Gordon and co-authors found that investigators completing negative studies are indeed significantly slower to publish.

Nevertheless, we do the research because we don’t know the answer! Negative studies are just as important to consumers as positive studies. They are essential blocks in the evidence base. They help everyone—consumers and health care providers—avoid interventions that don’t help.

There is an additional “silver lining.” Negative studies are extremely important in the research process. And the high-quality data produced during our well-performed, carefully monitored studies are of enormous value in deciding on follow-on questions and in the design of subsequent studies.

We learn from surprises—from discovering that we don’t always know what we think we know.

Wikipedia has been accepted world wide as a source of information by both lay people and experts. Its community driven approach has ensured that the information presented caters to a wide variety of people. An article from 2011 in the Journal of Medical Internet Research found that a significant number of experts and doctors consult Wikipedia’s medicine related topics.

Medical information is very dynamic and conclusions and recommendations are turned on their heads based on new findings. Taking this into account it is important to ensure that Evidence Based content is a part of any medicine related…

On average, new treatments perform better in clinical trials only slightly more often than existing treatments, according to a new systematic review published in The Cochrane Library. The fact that experimental treatments are not more effective may seem disappointing, but the authors of the review say their findings satisfy an important ethical requirement for clinical trials.

Randomised trials compare the effects of one treatment to another. In a randomised trial patients are randomly allocated to different treatment groups to ensure that like will be compared with like. When a new treatment is being tested, it is hoped or even expected that it will be better than the established treatment with which it is being compared. These expectations lead to an ethical dilemma. If the researchers already know that one treatment is better, they would be knowingly allocating some people to an inferior treatment. If randomised trials are to be ethical, therefore, only half of new treatments should turn out to be better than existing ones.

Related Resources

Cochrane Reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care. They investigate the effects of interventions for prevention, treatment and rehabilitation. They also assess the accuracy of a diagnostic test for a given condition in a specific patient group and setting. They are published online in The Cochrane Library.

Looking for the full text of these Cochrane Reviews? They may be available at your local public, academic, and medical libraries. Call ahead and ask for a reference librarian. Many academic and medical libraries do serve the public, providing at least some basic services.

This is the 14th annual workshop but this will be my first. I’ve always heard wonderful things about it from past participants – journalists, policymakers and public health professionals.

One of this year’s workshop themes will be screening tests – which any reader of this blog knows is a favorite topic of mine.

The organizers state:

The five-day workshop is an intense, hands-on learning experience that uses a small-group, problem-based approach to learning.

One of the small groups, supported by the NIH Office of Disease Prevention, will focus on using evidence to inform and improve reporting, policy decisions, public health decisions, clinical and personal decisions about screening.

Meantime, on the topic of screening, I finally read Alan Cassels’ book, “Seeking Sickness: Medical Screening and the Misguided Hunt for Disease.“ Alan published the Canadian equivalent of our HealthNewsReview.org project – the Canadian Media Doctor site. He’s let that project gather some dust while he works on other things like this book. I can’t quite seem to ever find time for my book idea because I’m so married to this site. Maybe he’s wiser. It seems impossible to do both.

Together, hip and knee replacement surgeries already represent the largest hospital expense for Medicare. And, according to an article in Time magazine, the money spent on these two procedures is expected to reach $65.2 billion by 2015.

There is no doubt that part of Medicare reform will involve looking at ways to reduce this cost. One approach is to move the choice of device away from vague “physician preference” and toward evidence-based criteria…

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he American Joint Replacement Registry was created recently, and just this January began a pilot project collecting hip and knee replacement information from 16 representative hospitals. In a statement, the organization (made up of surgeons, executives from the device industry, payers and patient representatives) said that its “long-term goal is to capture data from 90 percent of U.S. hospitals where hip and knee arthroplasty procedures are performed, which amounts to between 5,000 and 6,000 different hospitals, in the next 5 years.”

In the end, marketing devices directly to consumers is antithetical to these other measures that are designed to promote evidence-based treatments. …

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Unless insurers—both public and private—start using evidence-based decision making to set coverage for new hip implant devices, the number of younger patients undergoing more expensive procedures will likely rise—sometimes for the wrong reasons.

Some things in medicine are obvious. Despite the endless worship of ‘evidence-based’ medicine, and the constant barrage of studies on every conceivable topic, we do certain things because we know they just seem right. I take as evidence the fact that we daily try to save lives, devoting research time, untold gazillions of dollars and heroic clinical effort to our continued goal of staving off death. Why is this? Do we know that death is inherently worse than life? Well, since we can’t see beyond the grave, and can’t exactly engage in double-blind, placebo controlled studies about the after-life, the answer is “no.” But we assume that life is preferable to death, based on our feelings, our sense of the thing.

The same is true in our personal lives. No one can show me a scientific study that details why he or she married a particular person. No one can offer up a mole of affection for empiric analysis. And yet, we don’t doubt the existence of romance, or the reality of love.

And yet, medicine is filled with situations in which “self-evident truth” is systematically ignored, and those who believe in it intentionally and often viciously marginalized.

For example, after years of being told that physicians weren’t giving enough treatment for pain, and after years of clinicians saying, “yes we are, and too many people are addicted and abusing the system,” the data from CDC says that far too many are dying from prescription narcotics, far too many infants being born addicted, and far too many people, young and old, are using analgesics and other drugs not prescribed for them. To which many of us say, “duh!”

And then there’s the customer service model, the thing which causes clinicians to lose their jobs as satisfaction scores fall due to disgruntled patients (often upset over not receiving the drug they desired … see above paragraph). This is a darling of administrators. And it clearly has flaws…

Potentially inappropriate medications (PIMs) continue to be prescribed and used as ﬁrst-line treatment for the most vulnerable of older adults, despite evidence of poor outcomes from the use of PIMs in older adults. PIMs now form an integral part of policy and practice and are incorporated into several quality measures. The speciﬁc aim of this project was to update the previous Beers Criteria using a comprehensive, systematic review and grading of the evidence on drug-related problems and adverse drug events (ADEs) in older adults. This was accomplished through the support of The American Geriatrics Society (AGS) and the work of an interdisciplinary panel of 11 experts in geriatric care and pharmacotherapy who applied a modi- ﬁed Delphi method to the systematic review and grading to reach consensus on the updated 2012 AGS Beers Criteria. Fifty-three medications or medication classes encompass the ﬁnal updated Criteria, which are divided into three categories: potentially inappropriate medications and classes to avoid in older adults, potentially inappropriate medications and classes to avoid in older adults with certain diseases and syndromes that the drugs listed can exacerbate, and ﬁnally medications to be used with caution in older adults. This update has much strength, including the use of an evidence-based approach using the Institute of Medicine standards and the development of a partnership to regularly update the Criteria. Thoughtful application of the Criteria will allow for (a) closer monitoring of drug use, (b) application of real-time e-prescribing and interventions to decrease ADEs in older adults, and (c) better patient outcomes.

The Guide to Community Preventive Services is a great resource for what methods and interventions work well to improve public health. It is geared towards public health officials, researchers, and policy makers. However, it is also a good aid for anyone looking for the best way(s) to address issues touching family members and friends. The information can be used to promote or advocate for changes in policies and laws at local or national levels. They can be used to positively influence changes for the better in schools, workplaces, public health departments, and more.

A good way to start is through the Topics link at the top of the page. It includes links to issues as asthma, cancer, diabetes, nutrition, obesity, vaccines, and violence. Each topic includes links to more information on the topic and related topics.
Many topics have summaries of recommendations and findings. For example the topic Diabetes includes recommendations for certain disease management programs but insufficient evidence for self management programs in school settings or worksites.

All information on the interventions for a specific topic (as violence, diabetes, alcoholism) is carefully reviewed through a standardized step by step process. systematic reviews. Each reviews includes summarized results of all related evidence. These unbiased evidence-based reviews are also called systematic reviews.
[Click here for a good explanation of the systematic review process]

Each topic in this community guide answer questions such as: c

What interventions have and have not worked?

In which populations and settings has the intervention worked or not worked?

What might the intervention cost? What should I expect for my investment?

Does the intervention lead to any other benefits or harms?

What interventions need more research before we know if they work or not?

Systematic reviews are widely recognised as reliable sources of information about the effects of healthcare interventions. But as with individual research studies, they can be hard to find, may have flaws and can be difficult to interpret.

Since 1994, CRD has been producing and maintaining DARE, a database which uniquely provides access to over 11,000 abstracts of quality assessed and critically appraised systematic reviews. The database has become a key resource for health professionals and policy makers as it provides its users with a ‘bottom line’ on the overall validity and reliability of each review.

Deputy Director of CRD Dr Amanda Sowden said: “CRD aims to produce and disseminate high quality evidence to inform health care decision making in the UK and internationally. Our partnership with PubMed Health is an exciting and prestigious development that will help give our database content truly global reach.”

Update — PubMed Health December 2011 Release

With its December release, PubMed® Health grows to over 18,000 systematic reviews and health technology assessments in the last 10 years. With the inclusion of the Database of Reviews of Effects (DARE) from the Centre for Reviews and Dissemination in England, PubMed Health is getting close to comprehensive coverage of reliable systematic reviews on clinical effectiveness.

Addition of Over 12,000 Reviews from DARE

A new section in the “Contents” drop-down box on the homepage has been added for the DARE reviews (see Figure 1). This new content type rounds out PubMed Health’s coverage of systematic reviews on clinical effectiveness in the published biomedical literature, joining over 4,500 Cochrane reviews and hundreds of systematic reviews by health technology assessment agencies.

Figure 1: Contents drop-down box.

DARE is a key database produced by the Centre for Reviews and Dissemination (CRD) and funded by England’s National Institute of Health Research. Information specialists at CRD regularly search an extensive group of electronic databases, supplemented by hand searching, to identify published systematic reviews that meet their set of scientific criteria.

For about half of the reviews that qualify for DARE, a CRD summary with critical appraisal of the scientific quality of the review is added. These may raise caveats about the reliability of the review, as in the example featured in Figure 2.

PubMed Health displays the title of the review and its citation (see #1 in Figure 2). For those reviews with a full CRD summary and appraisal, the conclusion is then displayed, followed by a link to the complete version (see #2 in Figure 2). This is followed by the abstract of the review itself, if one is included in PubMed (see #3 in Figure 2).

Figure 2: Example of a DARE review with CRD summary.

Each PubMed Health record from DARE includes a link to an explanation of CRD’s process and assessment criteria.

Currently, DARE is added to weekly, and new records and summaries will appear shortly afterward in PubMed®Health. The records will not yet appear in PubMed.

Changes to Display of Search Results

DARE reviews are returned with all results, and can also be viewed under their own content type (see #1 in Figure 3).

Medical encyclopedia content has been simplified, with some content text also appearing (see #2 in Figure 3). Previously, only medical encyclopedia content for diseases and drugs were shown on the search results page. Relevant medical encyclopedia content for procedures and other types of searches now display.

Publishing a lay summary alongside every research article could be the answer to assisting in the wider understanding of health-related information.

Patients Participate! asked patients, the public, medical research charities and the research community, ‘How can we work together in making sense of scientific literature, to truly open up research findings for everyone who is interested?’ The answer came from patients who explained that they want easy-to-understand, evidence-based information relating to biomedical and health research.

Some universities now offer researchers training in communicating with lay audiences. (…)

JISC believes that publicly-funded research should be made available for everyone and be easy to find. JISC funded this work to show how making access to scientific literature enables citizen-patients to participate in the research process, therefore providing mutual understanding and better links between scientists, medic, patients and the general public.

To search for summaries, click on New Search (top of middle column) at “Summaries for Patients”
Once at the New Search Page (http://www.annals.org/search), be sure to check Summaries for Patients , under Limit Results by Section (Articles Published After 1927)

Pain at the end of life is everyone’s great fear, but we still do not know enough about what makes pain worse at the end of life. Studies of pain near death have mostly looked at specific types of patients, such as those with cancer or those who are in a hospice program in which a patient’s comfort and reducing pain is a main focus of care. Other studies have asked family members about their deceased or dying relative’s experience of pain in the last months of life, but these reports are affected by their feelings about the pain of their loved one. In addition, studies have generally not examined patients from national surveys that offer broader understanding of patients’ experience of moderate to clinically significant pain at the end of life.

What did the researchers find?

Among the more than 4700 patients in the study, about 25% had clinically significant pain. However, the proportion experiencing significant pain increased to nearly 50% in the last 4 months before death. One of the most important things that affected the amount of pain was having arthritis. Surprisingly, the reason that a person was dying, such as heart disease or cancer, was not associated with important differences in the amount of pain.

What were the limitations of the study?

No information about treatment for pain was provided, and the study did not follow specific patients over time to see how their pain changed. Some people with arthritis might have had pain from something else that they mistakenly thought was arthritis.

What are the implications of the study?

Physicians and patients are not good at knowing when death is close, so it is important long before the last few months of life to discuss pain and ways to reduce it. Arthritis may be an important cause of pain or death that could be reduced by lifestyle changes long before death.

patientINFORM plain language summary Web sitesare provided by participating publishers to help patients or their caregivers more fully understand the implications of research and to provide links to the full text of research articles they’ve selected from participating journals. The publishers allow readers following links from patientINFORM material on the health organizations’ sites to access the full text of these articles without a subscription, and they provide patients and caregivers with free or reduced-fee access to other articles in participating journals.

Journal of Rehabilitation Research and DevelopmentFor its nontechnical readers (e.g., veterans, patients, and caregivers), JRRD publishes plain-language summaries in each issue that describe the purpose and explain who may benefit from the research. These summaries are useful tools that keep patients and interested individuals informed of current research and encourage discussion of research between patients and their healthcare providers.

Consider asking a reference librarian for help at your local public, academic, or hospital library. Many academic and hospital libraries provide at least limited reference service to the public.
Call or email them for information about their services.

You may also contact me at jmflahiff@msncom. I will do my best to reply within 48 hours.

The art of medicine, the most important part of medicine, involves several components:

Caring for patients, showing honest concern and compassion

Giving patient’s time, not rushing in and out of the exam clinic room, being patient with them, having a great bedside manner

Using the evidence based medicine algorithms as a guideline, as we apply them to each and every patient we see. Understanding that every patient is an individual who has individual circumstances that affect their lives

Helping every patient to acquire the best outcome they can for themselves by working with them, educating them, coming up with a mutually agreed upon plan of action

Evidence based medicine does not teach us how to apply them to the patients we see, only the art of medicine does that. [Flahiff’s emphasis] Much unlike evidence based medicine we don’t learn the art of medicine in a classroom. We learn the art of medicine by seeing patients, one by one, year after year. As new research comes out and the evidence based medicine algorithms change, hopefully we have refined our art of medicine skills to such a fine point that we have attained the stature of a wise mentor….

The PubMed® Clinical Queries homepage will be slightly modified to provide users with a more straightforward understanding of how to enter a search (see Figure 1).

Figure 1: PubMed Clinical Queries homepage.

After running a search, the category/scope limits for the Clinical Query Study Categories secion and topic limits for the Medical Genetics section will be available on the preview results page (see Figure 2).

Don’t Cross Your Eyes…They’ll Get Stuck that Way!, a new book by myth-fighting Indiana University School of Medicine pediatricians Aaron Carroll, M.D., M.S., and Rachel Vreeman, M.D., M.S., debunks the pearls of medical wisdom that many people and even their physicians believe are true. Be prepared to revise your thinking; no, an apple a day won’t keep the doctor away and no, warm milk won’t help you sleep.

Dr. Carroll, associate professor of pediatrics, and Dr. Vreeman, assistant professor of pediatrics, are physicians and health services researchers on a mission to bring evidence-based medicine to the general public and slay the growing number of health myths that are so prevalent.

“You shouldn’t just accept that the toilet seat is the dirtiest place in the bathroom, or that the air on planes can make you sick, or that cell phones cause brain cancer. It’s OK to question your physician. Asking why is just as important as asking what,” said Dr. Vreeman.

Why do so many myths exist?

“People want to make sense of the world around them; if they read it in the paper or on the internet, or hear it on TV or from their mom or others in authority, they think it must be true. The difference between association and causation is being lost. Just because two things occur at nearly the same time or initially appear related, like vaccines and autism, for example, doesn’t mean that one caused the other,” said Dr. Carroll. …

..Don’t Cross Your Eyes…They’ll Get Stuck that Way! is published by St. Martin’s Press and is available online and at book stores across the country.

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About

This blog presents a sampling of health and medical news and resources for all. Selected articles and resources will hopefully be of general interest but will also encourage further reading through posted references and other links. Currently I am focusing on public health, basic and applied research and very broadly on disease and healthy lifestyle topics.

Several times a month I will post items on international and global health issues. My Peace Corps Liberia experience (1980-81) has formed me as a global citizen in many ways and has challenged me to think of health and other topics in a more holistic manner. (For those wishing to see pictures of a 2009 Friends of Liberia service trip to this West African country, please visit www.fol.org. My photo album is included).

Do you have an informational question in the health/medical area?
Email me at jmflahiff@yahoo.comI will reply within 48 hours.

My professional work experience and education includes over 10 years experience as a medical librarian and a Master’s in Library Science. In my most recent position I enjoyed contributing to our library’s blog, performing in depth literature searches, and collaborating with faculty, staff, students, and the general public.

While I will never be be able to keep up with the universe of current health/medical news,
I subscribe to the following to glean entries for this blog

Krafty (Medical)Librarian,” a collection of writings from Michelle Kraft on items of interest to medical librarians. She tends to write on technology and medical libraries but she also writes about things in general on librarianship, medicine and health”

Free Government Information, a “place for initiating dialogue and building consensus among the various players (libraries, government agencies, non-profit organizations, researchers, journalists, etc.) who have a stake in the preservation of and perpetual free access to government information”

Scout Report, a “weekly publication offering a selection of new and newly discovered Internet resources of interest to researchers and educators”